The invention relates generally to medical devices and, more particularly, relates to therapeutic applicator systems and methods locatable within body cavities.
Otitis media is a painful infection of the middle ear and ranks second only to the common cold as the most frequent illness among children in the United States. Acute otitis media is usually accompanied by fever, swelling, inflammation of the eardrum, and considerable pain. Otitis media develops when bacteria or viruses, usually associated with colds or sore throats, make their way up the eustachian tube, from the upper part of the throat behind the nose to the middle ear. As a result of the infection, the eardrum can become swollen and inflamed. When fluid accumulates against the eardrum, the condition is known as otitis media with effulsion or "glue ear." This condition can lead to hearing loss, and it may impair an affected child's learning and language skills.
Nearly 70% of U.S. children develop otitis media by age two. Because of the close anatomical relationship of the eustachian tube to the nasal cavity, otitis media is a frequent problem, especially in children in whom the tube is shorter, wider, and more horizontal than in adults. Many children outgrow their susceptibility to otitis media infection by age five. Over half of those children who experience acute otitis media have repeated episodes of the condition, and the condition may become chronic. Otitis media accounts for over 35% of all visits to pediatricians each year and represents more than $3.5 billion in U.S. health care costs annually.
Otitis media, with or without effusion, is also the most common reason antibiotics have been prescribed for children. The U.S. Food and Drug Administration (FDA) has found that about 14% of all courses of antibiotics prescribed in the United States are for otitis media. It has been shown that about 70% of ear infections have a bacterial etiology and 30% are viral in origin. Three types of bacteria, Streptococcus pneumoniae, Hemophilus influenza and Moraxella catarrhalis, cause 50% to 90% of middle ear infections. Many of these bacteria are now resistant to antibiotics. Furthermore, some children experience life threatening reactions to the antibiotics.
Conventional treatment for otitis media is implanting tubes in the eardrum to drain the middle ear, a surgical procedure known as tympanostomy. Tympanostomy is the most common surgery for otitis media. The surgical procedure requires administration of a general anesthetic and is typically performed on children under age two. In 1988, 800,000 children received 1.3 million tympanotomy tubes. Of these tubes, 30% were replacements. In 1986, 31 million visits to physicians were because of otitis media, and total direct and indirect costs for otitis media-related illnesses for that year have been estimated at $3.5 billion. Surgical costs, alone, for procedures for otitis media exceed $1.2 billion annually.
There are a number of risks of using ear tubes, including the following: risks associated with general anesthesia; tympanosclerosis occurs in about 51% of patients receiving ear tube implants; persistent otorrhea in 13% of ear tube patients; and an average 5-db hearing loss occurs to those receiving ear tubes. Beyond that, 30% of children receiving one set of tubes require a second set within five years of the first set. A study published in the Journal of the American Medical Association (JAMA), Apr. 27, 1994, found that 25% of tympanostomies were inappropriate. The study also found that, in about 30% of patients receiving tympanostomies, the benefits did not outweigh the risks of general anesthesia.
Another condition affecting the ear canal is otitis externa (commonly referred to as "swimmer's ear") which occurs in near-epidemic numbers during periods of hot, humid weather in which people spend time in swimming pools and enjoying aerobic exercises. Normally, cerumen (i.e., ear wax) and the acid pH of the external auditory canal protect the ear from infection. The canal can become infected, however, when the epithelium lining the canal becomes injured. This injury can occur through attempts to remove cerumen or entrapped water from the ear canal. In such instances, the epithelium can become macerated and susceptible to infection by Pseudomonas species, Staphylococcus aureus, and some fungi. The epithelium of the external auditory canal is tightly attached to the underlying bone or cartilage, and even a little swelling produces a great deal of pain in those affected. The macerated epithelial cells form a red and scaly dermatitis that may encroach on the epithelium of the tympanic membrane.
Otitis externa is treated by cleansing the canal with gentle curettage and irrigation and suction of the debris. Antibacterial, antifungal, or antiinflammatory medications, as well as drying-medications, are instilled into the ear canal. Fungal infections usually resolve when the acidic pH is restored. Acetic acid with steroids, or simply boric acid solution, alone, is generally adequate for immunocompetent patients. In diabetic or immunocompromised persons, however, otitis externa may progress to cellulitis of the scalp and osteomyelitis of the skull.
In conventional treatment of otitis externa, drying and medication is typically prescribed. A cellulose tampon (i.e., Pope ear wick) is sometimes inserted into the auditory canal and moistened with antibiotics to control the infection. Various drying-medications or steroids to relieve swelling may also be appropriate and may likewise be applied via the tampon or in other typical manners.
Certain conventional apparatus and methods provide for medicine application within body cavities, particularly the ear. For example, U.S. Pat. No. 5,417,224 to Petrus et al. discloses a tampon having loops through a spherical member for ease in removal from a body cavity. U.S. Pat. No. 3,528,419 to Joechle et al. discloses a resilient tampon impregnated with hormonal and steroidal preparations, which may be inserted into the auditory canal of domestic animals to affect reproductive physiology. U.S. Pat. No. 4,034,759 to Haerr discloses a hollow-cylindrical tube of cellulose material which may be inserted into the ear canal and which expands after the addition of medications. U.S. Pat. No. 4,159,719 also to Haerr discloses a tightly coiled moisture-expandable ear canal wick. U.S. Pat. No. 4,278,664 to Van Cleave discloses a preventative composition for the prevention of otitis externae. U.S. Pat. No. 4,938,959 to Martin et al. discloses a combination of an insoluble substance, such as nystatin, in powder or liquid form, mixed with soluble substances and applied to the ear canal. U.S. Pat. No. 4,995,867 to Zollinger discloses a syringe dispenser for the administration of medications to the ear canal. U.S. Pat. No. 5,107,861 to Narboni discloses an ear button for removing ear wax. Furthermore, U.S. Pat. No. 5,476,446 to Arenburg discloses a therapeutic treatment apparatus for use in the middle and inner ear for invasive microsurgical procedures.
Although the above-referenced patents address medicine application to body cavities, such as the ear, they do not provide for long-term, in-place treatment. Another disadvantage of the references is that the medicines and application mechanisms do not provide for easy removal from the body cavity.
What is needed, therefore, is a therapeutic applicator, and method of use thereof, which allows for long-term, in-place treatment of conditions within body cavities, such as the ear. Furthermore, easy removal of such a therapeutic applicator and method would be an added advantage and improvement.